ZipCombo Centrifuge with hematocrit and microtube rotors

FDA UDI

Class II (US FDA UDI)

by Lw Scientific, Inc.

Identity

Trade Name: ZipCombo Centrifuge with hematocrit and microtube rotors FDA UDI
Generic Name: Microhaematocrit centrifuge IVD FDA UDI
Device Name: ZipCombo Centrifuge, hematocrit and microtube rotors, capacity 12 hematocrit tubes (40mm) and 6 microtubes FDA UDI
Model / Reference: ZCC-1206-77T3 FDA UDI
Description: ZipCombo Centrifuge, hematocrit and microtube rotors, capacity 12 hematocrit tubes (40mm) and 6 microtubes FDA UDI

Identifiers

Primary DI / UDI-DI: 00664816001752 FDA UDI
FDA Product Code: GKG FDA UDI
GMDN Term: Microhaematocrit centrifuge IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.6400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Microhaematocrit centrifuge IVD

ZipCombo Centrifuge with hematocrit and microtube rotors by Lw Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Lw Scientific, Inc.

Sources (1)

FDA UDI fbeb8251-ba84-4cc2-93fe-344f530eabae 33 fields · synced May 31, 2026